IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This is a Phase 2b study to evaluate the efficacy and safety of IMVT-1402 in adults with CIDP.
Study details:
This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of IMVT-1402 in adult participants with active CIDP.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) Guideline on Diagnosis and Treatment of CIDP.
- Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.
- Additional inclusion criteria are defined in the protocol.
Exclusion criteria
- Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.
- Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN/PNS guideline on diagnosis and treatment of CIDP.
- Have polyneuropathy of causes other than CIDP including but not limited to: Multifocal motor neuropathy, Hereditary demyelinating neuropathy, Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS), Lumbosacral radiculoplexus neuropathy, Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies, Drug- or toxin-induced.
- Have diabetes mellitus (DM) and meets any of the following criteria: Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study; In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP; In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.
- Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT07032662
Intervention or treatment
DRUG: IMVT-1402
DRUG: Placebo
Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Site Number - 5102
Select from list below to view details:
Site Number - 5102
Brisbane, Australia
Site Number - 5100
Macquarie Park, Australia
Site Number - 5103
Parkville, Australia
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Who is running the clinical trial?
Immunovant Sciences GmbH
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Imeroprubart
| Drug: Imeroprubart |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants remaining Relapse-free by Week 24 | Relapse is defined as a worsening (increase) of ≥ 1 point on the adjusted inflammatory neuropathy cause and treatment (aINCAT) score at any time point relative to Period 1 Baseline. | Baseline, Week 24 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to Week 24 in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) | Not Specified | Baseline and Up to Week 24 |
| Change from baseline to Week 24 in Mean Grip Strength in the dominant hand | Not Specified | Baseline and Up to Week 24 |
| Change from baseline to Week 24 in Medical Research Council Sum Score (MRC-SS) | Not Specified | Baseline and Up to Week 24 |
| Change from baseline to Week 24 in aINCAT score | Not Specified | Baseline and Up to Week 24 |
References
Clinical Trials Gov: IMVT-1402 in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Other trials to consider
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